Aesthetic Dermatology

PHOENIX — California Governor Arnold Schwarzenegger signed a bill into law that raises public awareness about the risks of cosmetic surgery and targets the aggressive marketing of services that make the risks “seem almost nonexistent,” California State Assemblywoman Wilmer Amina Carter said.

Known also as the “Donda West Act,” the law is named after Kanye West's mother, who died of complications following liposuction and mammaplasty. The law requires a physical examination 30 days before a patient undergoes a cosmetic surgery procedure.

“People may think they are well enough for cosmetic surgery, but [they] are not always,” said Ms. Carter, who introduced the legislation, known officially as AB 1116. She spoke at the joint annual meeting of American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology & Aesthetic Surgery.

Earlier this year the governor vetoed a second patient safety bill also sponsored by Ms. Carter. That legislation would have increased enforcement of patient safety laws specifically addressing medi-spa-based cosmetic procedures and laser hair removal retail chains.

“The bill made it through with only one 'no' vote before Governor Schwarzenegger vetoed it,” said Dr. Robert A. Weiss, a private practice dermatologist in Hunt Valley, Md.

“We're having budgetary issues in California, as are most states. The Governor is very adamant about getting things done, and is holding some bills hostage to get things he wants done,” Ms. Carter, who introduced the bill to the assembly, said. “It is not the fault of the bill—it's relevant.”

Known as AB 252, the bill aimed to increase penalties and enforcement related to existing California law that prohibits corporate medi-spas and hair removal chains from hiring medical directors who provide supervision in name only. If it had become law, the Medical Board of California would be authorized to remove the medical license of any physician who allowed his or her license to be used for a nonphysician to establish a medi-spa, commonly known as a “rent-a-doc” scheme. The ASDS and CalDerm co-sponsored the bill.

“There is a growing trend for elective cosmetic surgery but the public is not always aware of the risks,” Ms. Carter said. She cited the case of a patient treated at a medi-spa located on an upper floor of a mall. Something went wrong, and there was no doctor on site. Ambulance workers could not get the patient down through the mall and the patient had to be lowered through a window. “It's those kinds of things we have to protect patients from.”

“When I became an elected official, I decided one of my goals was to author legislation to protect our citizens from harm,” Ms. Carter said. She vowed to continue working on patient safety issues.

PHOENIX — California Governor Arnold Schwarzenegger signed a bill into law that raises public awareness about the risks of cosmetic surgery and targets the aggressive marketing of services that make the risks “seem almost nonexistent,” California State Assemblywoman Wilmer Amina Carter said.

Known also as the “Donda West Act,” the law is named after Kanye West's mother, who died of complications following liposuction and mammaplasty. The law requires a physical examination 30 days before a patient undergoes a cosmetic surgery procedure.

“People may think they are well enough for cosmetic surgery, but [they] are not always,” said Ms. Carter, who introduced the legislation, known officially as AB 1116. She spoke at the joint annual meeting of American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology & Aesthetic Surgery.

Earlier this year the governor vetoed a second patient safety bill also sponsored by Ms. Carter. That legislation would have increased enforcement of patient safety laws specifically addressing medi-spa-based cosmetic procedures and laser hair removal retail chains.

“The bill made it through with only one 'no' vote before Governor Schwarzenegger vetoed it,” said Dr. Robert A. Weiss, a private practice dermatologist in Hunt Valley, Md.

“We're having budgetary issues in California, as are most states. The Governor is very adamant about getting things done, and is holding some bills hostage to get things he wants done,” Ms. Carter, who introduced the bill to the assembly, said. “It is not the fault of the bill—it's relevant.”

Known as AB 252, the bill aimed to increase penalties and enforcement related to existing California law that prohibits corporate medi-spas and hair removal chains from hiring medical directors who provide supervision in name only. If it had become law, the Medical Board of California would be authorized to remove the medical license of any physician who allowed his or her license to be used for a nonphysician to establish a medi-spa, commonly known as a “rent-a-doc” scheme. The ASDS and CalDerm co-sponsored the bill.

“There is a growing trend for elective cosmetic surgery but the public is not always aware of the risks,” Ms. Carter said. She cited the case of a patient treated at a medi-spa located on an upper floor of a mall. Something went wrong, and there was no doctor on site. Ambulance workers could not get the patient down through the mall and the patient had to be lowered through a window. “It's those kinds of things we have to protect patients from.”

“When I became an elected official, I decided one of my goals was to author legislation to protect our citizens from harm,” Ms. Carter said. She vowed to continue working on patient safety issues.

PHOENIX — California Governor Arnold Schwarzenegger signed a bill into law that raises public awareness about the risks of cosmetic surgery and targets the aggressive marketing of services that make the risks “seem almost nonexistent,” California State Assemblywoman Wilmer Amina Carter said.

Known also as the “Donda West Act,” the law is named after Kanye West's mother, who died of complications following liposuction and mammaplasty. The law requires a physical examination 30 days before a patient undergoes a cosmetic surgery procedure.

“People may think they are well enough for cosmetic surgery, but [they] are not always,” said Ms. Carter, who introduced the legislation, known officially as AB 1116. She spoke at the joint annual meeting of American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology & Aesthetic Surgery.

Earlier this year the governor vetoed a second patient safety bill also sponsored by Ms. Carter. That legislation would have increased enforcement of patient safety laws specifically addressing medi-spa-based cosmetic procedures and laser hair removal retail chains.

“The bill made it through with only one 'no' vote before Governor Schwarzenegger vetoed it,” said Dr. Robert A. Weiss, a private practice dermatologist in Hunt Valley, Md.

“We're having budgetary issues in California, as are most states. The Governor is very adamant about getting things done, and is holding some bills hostage to get things he wants done,” Ms. Carter, who introduced the bill to the assembly, said. “It is not the fault of the bill—it's relevant.”

Known as AB 252, the bill aimed to increase penalties and enforcement related to existing California law that prohibits corporate medi-spas and hair removal chains from hiring medical directors who provide supervision in name only. If it had become law, the Medical Board of California would be authorized to remove the medical license of any physician who allowed his or her license to be used for a nonphysician to establish a medi-spa, commonly known as a “rent-a-doc” scheme. The ASDS and CalDerm co-sponsored the bill.

“There is a growing trend for elective cosmetic surgery but the public is not always aware of the risks,” Ms. Carter said. She cited the case of a patient treated at a medi-spa located on an upper floor of a mall. Something went wrong, and there was no doctor on site. Ambulance workers could not get the patient down through the mall and the patient had to be lowered through a window. “It's those kinds of things we have to protect patients from.”

“When I became an elected official, I decided one of my goals was to author legislation to protect our citizens from harm,” Ms. Carter said. She vowed to continue working on patient safety issues.

Lumixyl is available for improving the appearance of hyperpigmentation, including melasma, sun spots, photodamage, age spots, liver spots, postinflammatory hyperpigmentation, and hyperpigmentation caused by systemic disease or prescription drugs. It is nontoxic, nonirritating, water soluble, and safe for all skin types. Formulated as an over-the-counter cream, Lumixyl is an alternative to hydroquinone, and is the only peptide capable of directly inhibiting tyrosinase, the enzyme responsible for initiating melanin synthesis in skin.

Basis Medical Technologieswww.lumixylmd.com

Lumixyl is available for improving the appearance of hyperpigmentation, including melasma, sun spots, photodamage, age spots, liver spots, postinflammatory hyperpigmentation, and hyperpigmentation caused by systemic disease or prescription drugs. It is nontoxic, nonirritating, water soluble, and safe for all skin types. Formulated as an over-the-counter cream, Lumixyl is an alternative to hydroquinone, and is the only peptide capable of directly inhibiting tyrosinase, the enzyme responsible for initiating melanin synthesis in skin.

Basis Medical Technologieswww.lumixylmd.com

Lumixyl is available for improving the appearance of hyperpigmentation, including melasma, sun spots, photodamage, age spots, liver spots, postinflammatory hyperpigmentation, and hyperpigmentation caused by systemic disease or prescription drugs. It is nontoxic, nonirritating, water soluble, and safe for all skin types. Formulated as an over-the-counter cream, Lumixyl is an alternative to hydroquinone, and is the only peptide capable of directly inhibiting tyrosinase, the enzyme responsible for initiating melanin synthesis in skin.

Basis Medical Technologieswww.lumixylmd.com

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

SAN FRANCISCO — Although changes to the aging face are often complex, knowing filler basics will help optimize results, Dr. Jason R. Michaels said.

“When I approach patients, I try to keep it as basic as possible: who, what, where, why, and when?” Dr. Michaels said. “It is almost back to the grammar lessons we had as kids.”

Even so, pairing the appropriate filler to each patient remains an art form. “Think of [fillers] as different types of paint brushes; and I choose depending on whether I want a broader effect or to treat more detail,” he said at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation (SDEF).

“I tend to look at faces in four different categories: furrows, folds, shaping, and volume,” said Dr. Michaels, associate clinical professor of dermatology at the University of Nevada, Las Vegas.

For correction of furrows, for example, options include finer-gauge fillers such as CosmoDerm (INAMED Aesthetics), Prevelle Silk (Mentor), Juvéderm Ultra (Allergan), and Restylane (Medicis Aesthetics). These products are generally safe for injections higher up in the skin. “My ideal choice is CosmoDerm because it works great on fine lines and wrinkles, but the downside is it does not last as long as some others,” Dr. Michaels said. He is a consultant for Allergan and a consultant and speaker for Medicis.

For treating folds, “the world is your oyster,” Dr. Michaels said. Examples include CosmoPlast (INAMED Aesthetics), Elevess (Anika Therapeutics), and Evolence (Ortho Dermatologics). The majority of his patients are aged 25–55 years and filler studies typically include 18- to 65-year-olds. However, “I inject patients well into their 70s and beyond and some teenagers.” Juvéderm UltraPlus, Perlane (Medicis), and Radiesse (BioForm Medical) are among his preferred products for folds, particularly in older patients.

Like other enhancements, shaping with fillers is technique dependent. “This is the art of doing fillers—you are creating a shape, defining some characteristic the patient has,” said Dr. Michaels. He prefers CosmoPlast, Juvéderm Ultra, or Restylane for shaping.

Volume replacement “is about quantity, and you need lots of product,” Dr. Michaels said. “Think of volume fillers as the rug pad under a rug.” Evolence, Perlane, Radiesse, and Sculptra (Sanofi-Aventis) are among the options for volume. “The problem with Sculptra is delayed gratification, which is not necessary a bad thing—some patients do not want their friends to know they used a filler,” Dr. Michaels said.

Filler products can be used in combination, which “is taking this to a new level,” Dr. Michaels said. “It is not uncommon for me to use two or three different fillers on the same patient.” An example of a combination is Perlane injected into the low dermis, Restylane in the mid-dermis, and CosmoDerm in the high dermis.

“Its limitation, of course, is going to be cost. Not everyone can afford that,” Dr. Michaels said.

Dr. Michaels urged caution with injection of fillers superficially “unless you have a lot of experience.” Even with the best intentions, fillers do not always end up at the level a physician perceives, “although the outcomes are fine,” according to a histologic study of hyaluronic filler injections in 16 patients (Dermatol. Surg. 2008;34:S56–62).

SDEF and this news organization are owned by Elsevier.

Click here to see a video of Dr. Michaels explaining his strategy for patients on a budget and for use of filler combinations.

SAN FRANCISCO — Although changes to the aging face are often complex, knowing filler basics will help optimize results, Dr. Jason R. Michaels said.

“When I approach patients, I try to keep it as basic as possible: who, what, where, why, and when?” Dr. Michaels said. “It is almost back to the grammar lessons we had as kids.”

Even so, pairing the appropriate filler to each patient remains an art form. “Think of [fillers] as different types of paint brushes; and I choose depending on whether I want a broader effect or to treat more detail,” he said at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation (SDEF).

“I tend to look at faces in four different categories: furrows, folds, shaping, and volume,” said Dr. Michaels, associate clinical professor of dermatology at the University of Nevada, Las Vegas.

For correction of furrows, for example, options include finer-gauge fillers such as CosmoDerm (INAMED Aesthetics), Prevelle Silk (Mentor), Juvéderm Ultra (Allergan), and Restylane (Medicis Aesthetics). These products are generally safe for injections higher up in the skin. “My ideal choice is CosmoDerm because it works great on fine lines and wrinkles, but the downside is it does not last as long as some others,” Dr. Michaels said. He is a consultant for Allergan and a consultant and speaker for Medicis.

For treating folds, “the world is your oyster,” Dr. Michaels said. Examples include CosmoPlast (INAMED Aesthetics), Elevess (Anika Therapeutics), and Evolence (Ortho Dermatologics). The majority of his patients are aged 25–55 years and filler studies typically include 18- to 65-year-olds. However, “I inject patients well into their 70s and beyond and some teenagers.” Juvéderm UltraPlus, Perlane (Medicis), and Radiesse (BioForm Medical) are among his preferred products for folds, particularly in older patients.

Like other enhancements, shaping with fillers is technique dependent. “This is the art of doing fillers—you are creating a shape, defining some characteristic the patient has,” said Dr. Michaels. He prefers CosmoPlast, Juvéderm Ultra, or Restylane for shaping.

Volume replacement “is about quantity, and you need lots of product,” Dr. Michaels said. “Think of volume fillers as the rug pad under a rug.” Evolence, Perlane, Radiesse, and Sculptra (Sanofi-Aventis) are among the options for volume. “The problem with Sculptra is delayed gratification, which is not necessary a bad thing—some patients do not want their friends to know they used a filler,” Dr. Michaels said.

Filler products can be used in combination, which “is taking this to a new level,” Dr. Michaels said. “It is not uncommon for me to use two or three different fillers on the same patient.” An example of a combination is Perlane injected into the low dermis, Restylane in the mid-dermis, and CosmoDerm in the high dermis.

“Its limitation, of course, is going to be cost. Not everyone can afford that,” Dr. Michaels said.

Dr. Michaels urged caution with injection of fillers superficially “unless you have a lot of experience.” Even with the best intentions, fillers do not always end up at the level a physician perceives, “although the outcomes are fine,” according to a histologic study of hyaluronic filler injections in 16 patients (Dermatol. Surg. 2008;34:S56–62).

SDEF and this news organization are owned by Elsevier.

Click here to see a video of Dr. Michaels explaining his strategy for patients on a budget and for use of filler combinations.

SAN FRANCISCO — Although changes to the aging face are often complex, knowing filler basics will help optimize results, Dr. Jason R. Michaels said.

“When I approach patients, I try to keep it as basic as possible: who, what, where, why, and when?” Dr. Michaels said. “It is almost back to the grammar lessons we had as kids.”

Even so, pairing the appropriate filler to each patient remains an art form. “Think of [fillers] as different types of paint brushes; and I choose depending on whether I want a broader effect or to treat more detail,” he said at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation (SDEF).

“I tend to look at faces in four different categories: furrows, folds, shaping, and volume,” said Dr. Michaels, associate clinical professor of dermatology at the University of Nevada, Las Vegas.

For correction of furrows, for example, options include finer-gauge fillers such as CosmoDerm (INAMED Aesthetics), Prevelle Silk (Mentor), Juvéderm Ultra (Allergan), and Restylane (Medicis Aesthetics). These products are generally safe for injections higher up in the skin. “My ideal choice is CosmoDerm because it works great on fine lines and wrinkles, but the downside is it does not last as long as some others,” Dr. Michaels said. He is a consultant for Allergan and a consultant and speaker for Medicis.

For treating folds, “the world is your oyster,” Dr. Michaels said. Examples include CosmoPlast (INAMED Aesthetics), Elevess (Anika Therapeutics), and Evolence (Ortho Dermatologics). The majority of his patients are aged 25–55 years and filler studies typically include 18- to 65-year-olds. However, “I inject patients well into their 70s and beyond and some teenagers.” Juvéderm UltraPlus, Perlane (Medicis), and Radiesse (BioForm Medical) are among his preferred products for folds, particularly in older patients.

Like other enhancements, shaping with fillers is technique dependent. “This is the art of doing fillers—you are creating a shape, defining some characteristic the patient has,” said Dr. Michaels. He prefers CosmoPlast, Juvéderm Ultra, or Restylane for shaping.

Volume replacement “is about quantity, and you need lots of product,” Dr. Michaels said. “Think of volume fillers as the rug pad under a rug.” Evolence, Perlane, Radiesse, and Sculptra (Sanofi-Aventis) are among the options for volume. “The problem with Sculptra is delayed gratification, which is not necessary a bad thing—some patients do not want their friends to know they used a filler,” Dr. Michaels said.

Filler products can be used in combination, which “is taking this to a new level,” Dr. Michaels said. “It is not uncommon for me to use two or three different fillers on the same patient.” An example of a combination is Perlane injected into the low dermis, Restylane in the mid-dermis, and CosmoDerm in the high dermis.

“Its limitation, of course, is going to be cost. Not everyone can afford that,” Dr. Michaels said.

Dr. Michaels urged caution with injection of fillers superficially “unless you have a lot of experience.” Even with the best intentions, fillers do not always end up at the level a physician perceives, “although the outcomes are fine,” according to a histologic study of hyaluronic filler injections in 16 patients (Dermatol. Surg. 2008;34:S56–62).

SDEF and this news organization are owned by Elsevier.

Click here to see a video of Dr. Michaels explaining his strategy for patients on a budget and for use of filler combinations.

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG